Glaucoma treatment devices and methods

ABSTRACT

Devices can be implanted in an eye to treat glaucoma. The devices described herein include a body defining a lumen and having first and second ends and external and lumenal surfaces. The body has a length sufficient to provide fluid communication between the anterior chamber and tear film of the eye through the lumen when the device is implanted in the sclera. By the strategic selection of particular materials of construction, and/or by controlling the configuration and size of the lumen, in some embodiments, the device is a filterless construct. In some embodiments, a filter is included. The glaucoma treatment devices as provided herein are designed to prevent bacterial ingress and to provide the required level of outflow resistance to achieve a desired intraocular pressure. Methods of treating glaucoma wherein the device is implanted in the sclera of an afflicted eye are also described.

CROSS REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional Ser. No.62/098,609 filed Dec. 31, 2014, and U.S. Provisional Ser. No. 62/235,113filed Sep. 30, 2015. This disclosure of the prior applications areconsidered part of (and are incorporated by reference in) the disclosureof this application.

BACKGROUND 1. Technical Field

This document relates to devices and methods for the treatment ofglaucoma. For example, this document provides devices configured forimplantation into the sclera of an afflicted eye to allow aqueous humorto flow from the anterior chamber of the afflicted eye through a lumenof the device and into the tear film, as well as methods for using suchdevices to treat glaucoma. This outflow of aqueous humor into the tearfilm can reduce the intraocular pressure of an afflicted eye in additionto providing moisture and lubrication on to the surface of the eye.

2. Background Information

Glaucoma is the leading cause of irreversible blindness in the world.About 105 million people worldwide have glaucoma, and nearly 10 millionare bilaterally blind from this disease. In the United States, over 3million people suffer from glaucoma, and it is the third most commonreason for adults to visit a medical doctor. Elevated intraocularpressure is the outstanding risk factor for the development of glaucoma,and the main reason for progression of the disease. Accordingly, onemode for treatment of glaucoma is directed to lowering the intraocularpressure in the affected eye.

SUMMARY

This document provides devices and methods for the treatment ofglaucoma. For example, this document provides devices configured forimplantation into the sclera of an afflicted eye to allow aqueous humorto flow from the anterior chamber of the afflicted eye through a lumenof the device and into the tear film, as well as methods for using suchdevices to treat glaucoma. By the strategic selection of particularmaterials of construction, and/or by controlling the shape and size ofthe lumen, in some embodiments, a device provided herein can befilterless, or can be designed to include a filter. A filterlessglaucoma treatment device described herein, or a glaucoma treatmentdevice having a filter as described herein, can be designed to preventbacterial ingress and to provide a desired level of outflow resistanceto achieve a desired intraocular pressure (typically a low to normal, orslightly above normal intraocular pressure) in glaucoma patients.Simultaneously, moisture and lubrication is provided to the surface ofthe eye to alleviate the dry eye symptoms commonly associated withglaucoma.

In one implementation, a device for treating glaucoma in an eye includesa body defining a lumen and having first and second ends, and externaland lumenal surfaces. The body has a length sufficient to provide fluidcommunication between an anterior chamber and a tear film of the eyethrough the lumen when the device is implanted in a sclera of the eye.The body may include a suture attachment feature configured forreceiving a suture to attach the body to the eye.

In another implementation, a device for treating glaucoma in an eyeincludes a body defining a lumen and having first and second ends, andexternal and lumenal surfaces. The body has a length sufficient toprovide fluid communication between an anterior chamber and a tear filmof the eye through the lumen when the device is implanted in a sclera ofthe eye. The body includes at least one lateral wing that includes asuture attachment feature configured for receiving a suture to attachthe body to the eye.

In another implementation, a device for treating glaucoma in an eyeincludes a body defining a lumen and having first and second ends, andexternal and lumenal surfaces. The body has a length sufficient toprovide fluid communication between an anterior chamber and a tear filmof the eye through the lumen when the device is implanted in a sclera ofthe eye. The lumen is open from the first end to the second end, and isconfigured to maintain a desired intraocular pressure without having aporous element inside the lumen.

In another implementation, a device for treating glaucoma in an eyeincludes a body defining a lumen and having first and second ends, andexternal and lumenal surfaces. The body has a length sufficient toprovide fluid communication between an anterior chamber and a tear filmof the eye through the lumen when the device is implanted in a sclera ofthe eye. The body may include one or more ribs extending longitudinallythrough at least a portion of the lumen, separating the lumen into openchannels.

Any one or more of the device implementations described above mayoptionally include one or more of the following features. The second endmay be flared. The lumen may be open from the first end to the secondend and configured to maintain a desired intraocular pressure without aporous element inside the lumen. The body may include one or more ribsextending longitudinally through at least a portion of the lumen. Thelumenal surface of the device may include a hydrophilic material. Thehydrophilic material may include polyethylene glycol. The externalsurface of the device may be coated with a hetero-bifunctionalcrosslinker to stimulate collagen binding. The hetero-bifunctionalcrosslinker may be 5-azido-2-nitrobenzoic acid N-hydroxysuccinimide. Insome embodiments, a porous element (e.g., a filter material and thelike) is positioned in the lumen.

In another implementation, a method for treating glaucoma includesproviding any one of the devices described herein, and implanting thedevice in the sclera of the eye such that aqueous humor flows from theanterior chamber to the tear film of the eye.

Such a method may optionally include one or more of the followingfeatures. After implanting the device, the second end may protrude fromthe eye by a distance in the range from about 100 μm to about 500 μm, orfrom about 50 μm to about 1000 μm. Such protrusion can be tolerated by apatient, as with each blink the rectus muscles retract the eyeball byabout 1000 μm. A portion of the second end may be flared or otherwiseextended, and a surface of the flared or extended portion may be incontact with the eye and generally follow a contour of the eye.

Particular embodiments of the subject matter described in this documentcan be implemented to realize one or more of the following advantages.In some embodiments, the devices provided herein drain aqueous humorinto the tear film, rather than into the subconjuctival space.Therefore, no conjunctival bleb is formed, and therefore there is nopotential to scar. Aqueous humor can be expelled into the tear film,thereby enhancing moisture and lubrication to the surface of the eye.Drainage of aqueous humor from the subject device into the tear film canalleviate dry eye symptoms in the glaucoma patients in which it isimplanted. In some embodiments, the lumen of the devices provided hereinis sized and/or provided with a surface chemistry to resist bacteriaingress. In addition, the geometry of the lumen can be selected toprovide a particular aqueous humor outflow resistance that yieldsdesirable intraocular pressure. By the selection of such a geometry, afilterless construct is facilitated in some embodiments. In someembodiments, a filter or filter-like element is included in the lumen.In some embodiments, the materials used to make a device provided hereincan be selected to provide bulk biocompatibility by seeking to matchscleral rigidity, and/or by providing a porous cellular ingrowth surfaceon the portion of the device that is in contact with eye tissue. In someembodiments, naturally occurring extracellular matrix proteins such ascollagen type 1, laminin, fibronectin, or other cell adhesion peptides(CAPs) can be grafted onto the outer surface to promote biointegration.In some cases, the inner or outer surfaces of the device can be coatedwith materials such as polymer coatings or biologically activemolecules, to promote surface biocompatibility and/or immobilization ofthe implanted device. Biointegration and scleral rigidity matching canserve to limit inflammation by limiting micromotion of the device. Insome embodiments, suture attachment features can be included to allowfor device stabilization before and during biointegration. In someembodiments, a protruding portion of the devices provided herein can beflanged or otherwise extended. Such flanged or extended portions mayprovide various benefits such as (i) providing a bolster to resistforces pushing the device in one direction or another, thereby, e.g.,resisting tipping or migration of the device, (ii) resisting growth ofconjunctiva over the exposed end of the device, and (iii) providing aninsertion depth control.

Unless otherwise defined, all technical and scientific terms used hereinhave the same meaning as commonly understood by one of ordinary skill inthe art to which this invention pertains. Although methods and materialssimilar or equivalent to those described herein can be used to practicethe invention, suitable methods and materials are described herein. Allpublications, patent applications, patents, and other referencesmentioned herein are incorporated by reference in their entirety. Incase of conflict, the present specification, including definitions, willcontrol. In addition, the materials, methods, and examples areillustrative only and not intended to be limiting.

The details of one or more embodiments of the invention are set forth inthe accompanying drawings and the description herein. Other features,objects, and advantages of the invention will be apparent from thedescription and drawings, and from the claims.

DESCRIPTION OF THE DRAWINGS

FIG. 1 is a sagittal cross-sectional schematic diagram of an eye withone embodiment of a device illustrative of the devices provided hereinimplanted in the eye.

FIG. 2 is a perspective view of an example device for treating glaucomain accordance with some embodiments.

FIG. 3 is a longitudinal cross-sectional view of the device of FIG. 2.

FIG. 4 is a schematic drawing of a sagittal cross-section of an eye(dividing the nasal and temporal halves of the eye) that shows examplegeometric relationships between the eye and an implanted device fortreating glaucoma.

FIG. 5 is a perspective view of another example device for treatingglaucoma in accordance with some embodiments.

FIG. 6 is a perspective view of another example device for treatingglaucoma in accordance with some embodiments.

FIG. 7 is a side view of the device of FIG. 6.

FIG. 8 is a sagittal cross-sectional schematic diagram of an eye withthe device of FIG. 6 implanted in the eye.

FIG. 9 is a perspective view of another example device for treatingglaucoma in accordance with some embodiments.

FIG. 10 is a side view of the device of FIG. 9.

FIG. 11 is a perspective view of another example device for treatingglaucoma in accordance with some embodiments.

FIG. 12 is a side view of the device of FIG. 11.

FIG. 13 is a perspective view of another example device for treatingglaucoma in accordance with some embodiments.

FIG. 14 is a side view of the device of FIG. 13.

FIG. 15 is a plan view of another example device for treating glaucomain accordance with some embodiments. An enlarged view of a portion ofthe lumenal structure is illustrated.

FIG. 16 is a plan view of another example device for treating glaucomain accordance with some embodiments. An enlarged view of a portion ofthe lumenal structure is illustrated.

FIG. 17 is a plan view of another example device for treating glaucomain accordance with some embodiments. An enlarged view of a portion ofthe lumenal structure is illustrated.

FIG. 18 is a plan view of another example device for treating glaucomain accordance with some embodiments. An enlarged view of a portion ofthe lumenal structure is illustrated.

FIG. 19 is a plan view of another example device for treating glaucomain accordance with some embodiments. An enlarged view of a portion ofthe lumenal structure is illustrated.

FIG. 20 is a plan view of another example device for treating glaucomain accordance with some embodiments. An enlarged view of a portion ofthe lumenal structure is illustrated.

FIG. 21 is a plan view of another example device for treating glaucomain accordance with some embodiments. An enlarged view of a portion ofthe lumenal structure is illustrated.

FIG. 22 is a plan view of another example device for treating glaucomain accordance with some embodiments. An enlarged view of a portion ofthe lumenal structure is illustrated.

FIG. 23 is a plan view of another example device for treating glaucomain accordance with some embodiments. An enlarged view of a portion ofthe lumenal structure is illustrated.

FIG. 24 is a plan view of another example device for treating glaucomain accordance with some embodiments. An enlarged view of a portion ofthe lumenal structure is illustrated.

FIG. 25 is a plan view of another example device for treating glaucomain accordance with some embodiments. An enlarged view of a portion ofthe lumenal structure is illustrated.

FIG. 26 is a plan view of another example device for treating glaucomain accordance with some embodiments. An enlarged view of a portion ofthe lumenal structure is illustrated.

FIG. 27 is an exploded perspective view of another example device fortreating glaucoma in accordance with some embodiments.

FIG. 28 is a side view of the device of FIG. 27.

FIG. 29 is an exploded perspective view of another example device fortreating glaucoma in accordance with some embodiments.

FIG. 30 is a side view of the device of FIG. 29.

FIG. 31 is a sagittal cross-sectional schematic diagram of an eye withanother embodiment of a device illustrative of the devices providedherein implanted in the eye.

FIG. 32 is a perspective view of another example device for treatingglaucoma in accordance with some embodiments.

FIG. 33 is a perspective view of another example device for treatingglaucoma in accordance with some embodiments.

FIG. 34 is a photograph of an example eye shortly after receiving animplantation of two devices in accordance with some embodiments.

FIG. 35 is a photograph of the eye of FIG. 34 two weeks after theimplantation.

FIG. 36 is a photograph of the eye of FIG. 34 one month after theimplantation.

FIG. 37 is an exploded perspective view of another example device fortreating glaucoma in accordance with some embodiments.

FIG. 38 is a side view of the device of FIG. 37.

FIG. 39 is a sagittal cross-sectional schematic diagram of an eye withthe device of FIG. 37 implanted in the eye.

FIG. 40 is an exploded plan view of an example deployment tool and adevice for treating glaucoma.

FIG. 41 is an exploded side view of the example deployment tool and thedevice for treating glaucoma of FIG. 40.

Like reference numbers represent corresponding parts throughout.

DETAILED DESCRIPTION

This document provides devices and methods for the treatment ofglaucoma. For example, this document provides devices configured forimplantation into the sclera of an afflicted eye to allow aqueous humorto flow from the anterior chamber of the afflicted eye through a lumenof the device and into the tear film, as well as methods for using suchdevices to treat glaucoma. By the strategic selection of particularmaterials of construction, and/or by controlling the shape and size ofthe lumen, in some embodiments, a device provided herein can befilterless, or can be designed to include a filter. A filterlessglaucoma treatment device described herein, or a glaucoma treatmentdevice having a filter as described herein, can be designed to preventbacterial ingress and to provide a desired level of outflow resistanceto achieve a desired intraocular pressure (typically a low to normal, orslightly above normal intraocular pressure) in glaucoma patients. Theflow of aqueous humor from the anterior chamber also provides moistureand lubrication to the surface of the eye to alleviate the dry eyesymptoms commonly associated with the use of eye drops for treatingglaucoma.

Referring to FIG. 1, an example device 1 is shown implanted in anafflicted eye 20 for the purpose of treating glaucoma of afflicted eye20. The depicted anatomical features of eye 20 include an anteriorchamber 2, a sclera 6, a tear film 4, an iris 23, a ciliary body 25, anda cornea 21. Device 1 includes a body 3 that defines a lumen 5. Body 3includes a first end 7 and a second end 9. Body 3 has an externalsurface 10, and a lumenal surface 12.

As depicted, device 1 is configured to be surgically implanted in sclera6 of eye 20. Device 1 has a length sufficient to provide fluidcommunication between anterior chamber 2 and tear film 4 of eye 20 whendevice 1 is implanted in sclera 6.

As described further herein, in some embodiments, lumen 5 can be sizedand configured to provide an appropriate outflow resistance to modulateaqueous humor flowing through lumen 5, without an element that providesadditional flow resistance (e.g., a filter or a porous element). Indoing so, lumen 5 functions to maintain a desired intraocular pressure(TOP) to treat a glaucoma-afflicted eye 20, while also providingmoisture and lubrication to the surface of eye 20 and tear film 4. Inother words, aqueous humor is shunted directly to tear film 4. Noconjunctival bleb is formed. Additionally, no episcleral venous pressure(EVP) is created that could raise nocturnal IOP. EVP is unaffected bythe use of the devices and methods provided herein. In some cases, adevice provided herein can define a lumen that includes a filter or aporous element.

In some cases, to provide fluid communication between anterior chamber 2and tear film 4, device 1 has a length of about 2.5 mm. In someembodiments, device 1 has a length of between about 2.5 mm and about 5.0mm, or between about 3.5 mm and about 6.0 mm. The length of at leastabout 2.5 mm will reduce the possibility of blockage of the lumenalopening in anterior chamber 2 by iris 23. The length of device 1 withinthe scleral tract would preferably be greater than the scleralthickness, because insertion would not be perpendicular to sclera 6 (butmore tangential) to be parallel to iris 23.

Referring also to FIGS. 2 and 3, additional details and features ofexample device 1 are visible therein. FIG. 3 is a longitudinalcross-sectional view of device 1 along section line 3-3 as shown in FIG.2. It should be understood that one or more (or all) of the details andfeatures described herein in reference to example device 1 are alsoapplicable to the other device embodiments provided herein.

In some embodiments, the main structure of body 3 is formed of amaterial such as, but not limited to, SU-8, parylene, thiolene,silicone, acrylic, polyimide, polypropylene, polymethyl methacrylate,polyethylene terephthalate (PET), polyethylene glycol (PEG), andexpanded polytetrafluoroethylene (e.g., denucleated and coated withlaminin). In some embodiments, the main structure of body 3 is formed ofa combination of two or more materials. For example, in someembodiments, a layer of PEG is sandwiched between an upper layer of PETand a lower layer of PET. The PEG can be used to define lumen 5, in someembodiments. The use of PEG for the surfaces of the lumen can beadvantageous because PEG resists bacterial, protein, and cell adherence.

In some embodiments, a portion of external surface 10 of body 3 iscoated with a coating such as a silicone coating or other type ofcoating. In some embodiments, substantially the entire external surface10 is coated with a coating such as a silicone coating or other type ofcoating. In particular embodiments, one portion of external surface 10may be coated with silicone, and other one or more portions may becoated with another type or types of coatings. Embodiments that includea silicone coating on portions or all of external surface 10 may becoated with a layer of silicone about 50 μm thick, or within a rangefrom about 40 μm to about 60 μm thick, or within a range from about 30μm to about 70 μm thick, or within a range from about 20 μm to about 80μm thick, or thicker than about 80 μm.

In some embodiments, external surface 10 of body 3 includes a porouscellular ingrowth coating on at least a portion thereof. In someembodiments, the portion of external surface 10 that is coated with thecellular ingrowth coating corresponds substantially to the portion ofbody 3 in contact with eye tissue (e.g., sclera 6) following scleralimplantation. Such porous cellular ingrowth coatings have been describedwith respect to other ophthalmic implants, and can be made of siliconewith a thickness of about 0.04 mm, in some examples. In someembodiments, surface laser engraving can be used to make depressions ina portion of the body surface to allow cellular ingrowth. Selectedgrowth factors may be adsorbed on to this coating to enhance cellularingrowth. Coating external surface 10 with a hetero-bifunctionalcrosslinker allows the grafting of naturally occurring extracellularmatrix proteins such as collagen type 1, laminin, fibronectin, or othercell adhesion peptides (CAPs) to external surface 10. These can attractfibroblasts from the episclera to lead to collagen immobilization ofdevice 1. One example of a hetero-bifunctional crosslinker that isuseful for such a purpose is 5-azido-2-nitrobenzoic acidN-hydroxysuccinimide.

In some embodiments, one or more portions of body 3 may be configured toinhibit conjunctival overgrowth. For example, second end 9 (of which atleast a portion thereof extends exterior to cornea 21) can be configuredto inhibit conjunctival overgrowth. Preventing such conjunctivalovergrowth can advantageously facilitate patency of lumen 5. In somesuch embodiments, a coating such as a PEG coating can be applied tosecond end 9 to inhibit conjunctival overgrowth.

In some embodiments, a bio-inert polymer is included as a liner of lumen5. That is, in some embodiments, lumenal surface 12 includes a bio-inertpolymer material. For example, in some embodiments, a material such as,but not limited to, polyethylene glycol (PEG), phosphoryl choline (PC),or polyethylene oxide (PEO) can be used for the lumenal surface 12 oflumen 5. Such bio-inert surfaces may be further modified withbiologically active molecules such as heparin, spermine, surfactants,proteases, or other enzymes, or other biocompatible chemicals amendableto surface immobilization or embedding. Some such materials areadvantageously hydrophilic. For example, in some embodiments, thehydrophilic properties of lumenal surface 12 can help prevent bacterialcontamination of device 1.

In some embodiments, a filter or filter-like porous member is includedin the device's flow path (e.g., lumen 5) for the aqueous humor. In someembodiments, no filter or porous member is present in lumen 5 for thepurpose of resisting ingress of bacteria. In some cases, the surfacechemistry of lumen 5 of a device provided herein can be used to preventbacterial ingress. For example, the high molecular weight PEG lininglumen 5 can be very hydrophilic and can attract a hydration shell. Themotility of the PEG side chains, and steric stabilization involvingthese side chains, also can repulse bacteria, cells, and proteins. Insome cases, the shear stress of the laminar flow of the aqueous humor asit leaves eye 20 can resist ingress of bacteria into device 1.Experiments demonstrated that when perfusing device 1 into an externalbroth with 10⁸ bacteria per mL, no bacteria entered device 1. Tears areusually quite sterile and have IgA, lysozyme, lactoferrin, andIgG/complement if inflamed. In some cases, tears can be used to clear aninfection.

In some embodiments, device 1 is constructed using bulk and surfacemicro-machining. In some embodiments, device 1 is constructed using 3Dmicro-printing.

In particular embodiments, external surface 10 is textured such as bystippling, cross-hatching, waffling, roughening, placing backwardsfacing barbs or protrusions, and the like. One way to accomplish thisexternal surface texturing is by laser engraving. Such featuring canstabilize device 1 in situ and also can increase the visibility ofdevice 1 by making it less transparent. The featuring of the externalsurface 10 can make device 1 more visible to a surgeon, thereby makingthe handling and deployment process of device 1 more efficient andconvenient.

In some embodiments, the width W of device 1 is in a range from about0.7 mm to about 1.0 mm, or from about 0.9 mm to about 1.2 mm, or fromabout 1.1 mm to about 1.4 mm, or from about 1.3 mm to about 1.6 mm, orfrom about 1.5 mm to about 1.8 mm, or greater than about 1.8 mm.

In the depicted embodiment, body 3 flares and/or extends out around atleast part of second end 9. The flaring of body 3 at its second end 9provides a number of advantages. For example, flaring of body 3 at itssecond end 9 aids in the surface mounting of device 1 in eye 20 byproviding an endpoint of insertion as device 1 is pushed into sclera 6during surgery. Additionally, the flaring of body 3 at its second end 9provides structural support to bolster the portion of device 1 thatprotrudes from eye 20. Such structural support can help maintain patencyof lumen 5 by resisting deflection of the protruding portion, which maytend to occur from the forces exerted by an eyelid, for example. Forinstance, such a posteriorly placed flare/extension bolsters the deviceagainst posterior pressures. In some cases, the flaring/extending ofbody 3 at its second end 9 provides additional resistance to growth ofconjunctiva over the exposed second end 9. For example, the additionalsurface area provided by the flared portion may tend to make growth ofconjunctiva over the exposed second end 9 less likely to occur, therebyhelping to maintain patency of lumen 5.

In some cases, device 1 can be anteriorly beveled at its first end 7 toassist in implantation and to keep the iris from plugging the innerlumenal opening.

In the depicted embodiment, lumen 5 is a narrow slit with a generallyrectangular cross-section. This narrow slit may contain a number oflongitudinal channels, which themselves may be square, rectangular,circular, or the like, and combinations thereof. In some embodiments,the total width of lumen 5 is about 0.5 mm. In some embodiments, thetotal width of lumen 5 is in a range from about 0.4 mm to about 0.6 mm,or about 0.3 mm to about 0.7 mm, or about 0.2 mm to about 0.8 mm. Theheight, effective width, configuration, and length of lumen 5 can beselected to provide a total resistance so that a desirably low TOP fromabout 8 mm Hg to about 12 mm Hg is maintained. This TOP is sometimescalled the threshold pressure, which is the TOP at which pressure doesnot contribute to loss of retinal ganglion cells over and above thenormal age-related loss. The devices provided herein for providingglaucoma treatment can be configured to attain the threshold pressure,without inducing hypotony.

The effective width of lumen 5 is that width obtained after subtractingthe total width of all the device support ribs 13 (as shown in FIG. 2).In some implementations, it is desirable to achieve a normal aqueoushumor outflow resistance of about 3.2 mmHg×min/μL. In someimplementations, there is some tolerance in the system, since theaqueous humor outflow even in a glaucomatous eye is rarely zero. Infact, the main natural aqueous humor outflow of the eye, theconventional or trabecular meshwork pathway, is TOP dependent and canmodify TOP swings. Poiseuille's equation for laminar flow though aporous media (R=8×viscosity×channel length/channel number×π×channelradius to the fourth power) can be used to determine the combination oflumen dimensions to give the proper resistance to provide the desiredTOP.

In the depicted embodiment, device 1 includes a suture attachmentfeature 11. In the depicted embodiment, suture attachment feature 11 isa through-hole that extends completely through body 3. Suture attachmentfeature 11 can receive a suture therethrough, whereby body 3 is attachedto eye 20. In some implementations, such suture(s) can stabilize device1 in eye 20 prior to bio-integration of device 1 with eye 20. In someembodiments, one or more other types of suture attachment features areincluded such as a flange, a slot, a projection, a clamp, and the like.In the depicted embodiment, suture attachment feature 11 is arectangular hole. In some embodiments, suture attachment feature 11 is acircular hole, ovular hole, or another shape of hole.

In some embodiments, suture attachment feature 11 is sized large enoughto receive a 10-0 spatula needle. For example, in some embodiments, thedimensions of suture attachment feature 11 is about 300 μm by about 200μm. Other appropriate sizes for suture attachment feature 11 can beused.

In some embodiments, one or more longitudinal support ribs 13 isincluded within lumen 5. Support rib 13 can add structural rigidity tohelp maintain patency of lumen 5. In some embodiments, support rib 13includes a series of short discontinuous ribs that are disposed alonglumen 5. In some embodiments, no support rib 13 is included.

In some embodiments, longitudinal support ribs 13 can divide lumen 5into two or more portions (e.g., channels). That is, in someembodiments, lumen 5 of body 3 includes two or more channels (e.g., two,three, four, five, six, or more than six channels). Aqueous outflow canoccur through these channels, which may be square, rectangular,circular, and the like, and combinations thereof.

In some embodiments, the portion of body 3 that is in contact with eyetissue following implantation includes one or more barbs designed toengage with tissue upon implantation and provide stability to implanteddevice 1. The one or more barbs may be formed as part of device body 3during manufacture, or may be fused or bonded to device body 3 using anyappropriate technique.

It should be understood that one or more (or all) of the details andfeatures described herein in reference to example device 1 are alsoapplicable to the other device embodiments provided herein. Moreover,one or more of the device details and features described herein can becombined with one or more other device details and features describedherein to create hybrid device constructions, and such hybrid deviceconstructions are within the scope of this disclosure.

Referring also to FIG. 4, certain geometric aspects of device 1 inrelation to eye 20 can be described. Device 1 is shown implanted at thelimbus of eye 20. The dimension X is the anterior protrusion of device 1from the scleral surface, and the dimension Y is the posteriorprotrusion of device 1 from the scleral surface. In the depictedimplementation, dimensions X and Y are about the same because flarebevel angle Z follows the contour of eye 20 (e.g., angle θ is about 40°to 45° in the depicted implementation). The posterior flare and/orextension also follows the contour of eye 20. Protrusion of device 1from the scleral surface can prevent conjunctival overgrowth. In somecases, this advantage should be balanced with the fact that increasedprotrusion may tend to make for increased micromotion in some cases. Insome embodiments, protrusion dimensions X and Y are in a range fromabout 50 μm to about 1000 μm, or from about 50 μm to about 200 μm, orfrom about 100 μm to about 300 μm, or from about 200 μm to about 400 μm,or from about 300 μm to about 500 μm, or from about 400 μm to about 600μm, or from about 500 μm to about 700 μm, or from about 600 μm to about800 μm, or from about 700 μm to about 900 μm, or from about 800 μm toabout 1,000 μm.

Dimension A in FIG. 4 is the thickness of device 1. Dimension B is thefrontal view thickness of the flared portion of device 1. In someembodiments, facial dimensions A and B are about 200 μm. Dimension B canvary in correspondence to variations in selected protrusion dimensions Xand Y.

Referring to FIG. 5, another example device 100 in accordance with someembodiments provided herein is illustrated. Device 100 includes a body103 that defines a lumen 105. Body 103 includes a first end 107 and asecond end 109. Body 103 has an external surface 110 and a lumenalsurface 120.

Device 100 can be constructed using any of the materials and techniquesas described above in reference to device 1. In some cases, device 100can be configured and used as described above in reference to device 1.Device 100 differs from device 1, at least in regard to, the addition oflateral wings 110 a and 110 b. Further, in the depicted embodiment ofdevice 100, device 100 does not include suture attachment feature 11 asincluded in device 1. Rather, device 100 includes suture attachmentfeatures 111 a and 111 b that are disposed in wings 110 a and 110 b,respectively. Each of suture attachment features 111 a and 111 b can beconfigured like suture attachment feature 11 of device 1 as describedabove.

A first method for installing the devices provided herein is as follows.Sometime before installation, the eye is irrigated with 1-5% Betadinesolution, and topical antibiotic and non-steroidal anti-inflammatorydrops (NSAID) are applied to the operative eye. These can be continuedfor about one week postoperatively four times a day. The NSAID helpsstabilize the blood-aqueous barrier.

Each of the embodiments of the device illustrated herein may be insertedunder topical anesthesia, possibly supplemented subconjunctivally. Ingeneral, the devices provided herein may be inserted into the sclera andunder the conjunctiva, using an operative procedure. The location ofinsertion of a device provided herein can be in the sclera at about theposterior surgical limbus. In some cases, a device provided herein canbe inserted at any site around the limbus. In some cases, a deviceprovided herein can be inserted at the superior or temporal limbus.

In some cases, the insertion procedure can begin by excising a smallamount of conjunctiva at the site of the anticipated insertion, exposingthe underlying sclera. In some cases (as described further below), theinsertion procedure is performed without the excision of conjunctiva.Any bleeding can then be cauterized. For embodiments of the device asshown in FIG. 5, a groove incision can be made at the site of insertionwith a diamond blade with a depth guard to a depth sufficient to coverthe entire length of wings 110 a and 110 b when the device is in place.Wings 110 a and 110 b can provide an end-stop for insertion, so theflare at end 109 of device 100 is optional. This groove incision can bemade at or near the posterior surgical limbus and can be parallel to theiris plane. For the embodiment of device 1 of FIG. 2, no groove incisionis needed, since this is only necessitated by wings 110 a and 110 b. Insome cases, for device 1, only a straight stab incision is used, withthe end-stop for insertion depth provided by the flare/extension at theouter end of the device. In some cases, for device 1, insertion can bemade through intact conjunctiva.

Approximately 1-2 mm posterior to the limbus, at the site of the nowexposed sclera, a diamond blade can be used to make a stab incision intothe anterior chamber, while held roughly parallel to the iris. Thisblade is of a size predetermined to make an opening into the anteriorchamber sized appropriately for the introduction of the device. Thisstab incision is made gently, but relatively quickly, assiduouslyavoiding any and all intraocular structures. Such an uneventfulparacentesis has been found not to disrupt the blood-aqueous barrier inmost cases. In any event, any disruption of this barrier is usually ofless than 24 hours duration without continued insult.

The device is next picked up and held with a non-toothed forceps. Thelips of the stab incision wound may be gaped with a fine, toothedforceps. The pointed tip of the tube element would then be gently pushedthrough the scleral tract of the stab incision and into the anteriorchamber, with the device lying above and parallel to the iris, with thebevel up (i.e., anteriorly). The flare/extension in the embodiments ofdevice 1 and device 100 provide for a definite endpoint to the depth ofinsertion. For embodiments of the device having a beveled first end, thebevel is oriented anteriorly to minimize the potential for blockage ofthe lumenal opening by the iris. The scleral barb(s) or other outersurface features (if included) stabilize the device until thebiointegration with the sclera is complete. This biointegration is afunction of its porous cellular ingrowth surface, possibly enhanced byadsorbed growth factors and/or grafted extracellular matrix proteins. Inaddition, in some implementations, one or more sutures may be addedusing the device's suture attachment features to stabilize the deviceprior to biointegration. For example, in the embodiments of device 1 anddevice 100, a 10-0 nylon suture on a broad spatula needle may be used tosuture the device the sclera, providing additional stability to thedevice until the biointegration is complete. This suture may then beeasily removed at a later time if needed. An alternative insertiontechnique would have the device pre-loaded into an insertion holder orcartridge, to limit the needed handling of the device by the surgeon. Aproperly sized sharp blade could be at the leading edge of the inserter,such blade acting also as a guide for implanting the device.Alternatively, the paracentesis could be made with a separate blade,followed by controlled insertion with an inserter.

After insertion of the device, an ocular shield can be placed over theeye. The implanted device will bio-integrate with the sclera, therebyreducing the risks of infections such as tunnel infection.

Referring to FIGS. 6 and 7, another example device 600 in accordancewith some embodiments provided herein is illustrated. Device 600includes a body 603 that defines a lumen 605. Body 603 includes a firstend 607 and a second end 609. Body 603 has an external surface 610 and alumenal surface 612.

Device 600 can be constructed using any of the materials and techniquesas described herein in reference to device 1. Also, device 600 can beconfigured and used in any of the manners described herein in referenceto device 1.

In the depicted embodiment, first end 607 is generally orthogonal inrelation to the longitudinal surfaces of external surface 610. Incontrast, second end 609 of the depicted embodiment is beveled inrelation to the longitudinal surfaces of external surface 610. It shouldbe understood that, in some embodiments of device 600 and the otherdevices provided herein, both ends 607 and 609 may be beveled (e.g.,like second end 609), both ends 607 and 609 may be orthogonal (e.g.,like first end 607), or either one of ends 607 or 609 may be beveledwhile the other one of ends 607 or 609 is orthogonal.

In the depicted embodiment, lumen 605 includes a first longitudinal rib613 a and a second longitudinal rib 613 b. While in the depictedembodiment, the ribs 613 a and 613 b extend continuously from first end607 to second end 609, in some embodiments, ribs 613 a and 613 b may bemade of multiple individually shorter segments and/or otherarrangements. It should be understood that lumen 605 may be configuredwith any of the lumenal constructs provided herein (e.g., FIGS. 15-26,and others), and combinations thereof.

In the depicted embodiment, second end 609 includes a first flangeportion 614 a and a second flange portion 614 b that extend laterally inrelation to the longitudinal axis of body 603. In some implementations,surfaces of flange portions 614 a and 614 b contact the surface of thecornea and provide mechanical stabilization of device 600 in relation tothe eye. The outermost lateral surfaces of flange portions 614 a and 614b are radiused (contoured) in the depicted embodiment. In someembodiments, the outermost lateral surfaces of flange portions 614 a and614 b are planar and parallel to the longitudinal surfaces of externalsurface 610. In some embodiments, the outer lateral surfaces of flangeportions 614 a and 614 b are planar and unparallel or askew in relationto the longitudinal surfaces of external surface 610.

In some embodiments, one or more suture attachment features are includedon device 600 (and the other devices provided herein). In the depictedembodiment, second end 609 includes a first suture attachment structure616 a and a second suture attachment structure 616 b. The sutureattachment structures 616 a and 616 b are slots in the depictedembodiment. In some embodiments, other types of suture attachmentstructures can be alternatively or additionally included. While thedepicted embodiment includes two suture attachment structures 616 a and616 b, in some embodiments, zero, one, three, four, or more than foursuture attachment structures are included.

One or more portions of external surface 610 can be configured forenhanced friction with eye tissue (e.g., the cornea or sclera).Advantageous mechanical stability and/or migration resistance of thedevice 600 (and the other devices provided herein) in relation to theeye can be facilitated by such portions. For example, in the depictedembodiment, a surface portion 618 includes an enhanced texture(roughness) in comparison to other portions of external surface 610. Inthe depicted embodiment, surface portion 618 is a waffled surface(cross-hatched). In some embodiments, other types of texturingconfigurations can be alternatively or additionally included. Forexample, such texturing configurations can include, but are not limitedto, stippling, knurling, inclusion of one or more barbs, and the like,and combinations thereof. In some embodiments, the surface portion 618is created by techniques such as, but not limited to, laser machining,chemical etching, 3D printing, photo etching, and the like.

Referring to FIG. 8, device 600 is shown implanted in afflicted eye 20for the purpose of treating glaucoma of afflicted eye 20. The depictedanatomical features of eye 20 include anterior chamber 2, sclera 6, tearfilm 4, iris 23, ciliary body 25, and cornea 21. Device 600 includesbody 603 that defines lumen 605. Body 603 includes first end 607 and asecond end 609. Body 603 has an external surface 610, and a lumenalsurface 612.

As depicted, device 600 (and the other devices provided herein) isconfigured to be surgically implanted in sclera 6 of eye 20. Device 600has a length sufficient to provide fluid communication between anteriorchamber 2 and tear film 4 of eye 20 when device 600 is implanted insclera 6. As described further below, in some embodiments lumen 605 issized and configured to provide an appropriate outflow resistance tomodulate aqueous humor flowing through lumen 605, without the need foran element that provides additional flow resistance (e.g., a filter or aporous element). In doing so, lumen 605 functions to maintain a desiredTOP to treat a glaucoma afflicted eye 20, while also providing moistureand lubrication to the surface of eye 20 and tear film 4. In someembodiments, a filter or filter-like porous element is includes in lumen605.

In general, to provide fluid communication between anterior chamber 2and tear film 4, in some embodiments, device 600 has a length of about2.5 mm. In some embodiments, device 600 has a length of from about 2.5mm to about 5.0 mm, or from about 3.5 mm to about 6.0 mm. The length ofat least about 2.5 mm will reduce the possibility of blockage of thelumenal opening in anterior chamber 2 by iris 23. The length of device600 within the scleral tract would preferably be greater than thescleral thickness, because insertion would not be perpendicular tosclera 6 (but more tangential) to be parallel to iris 23.

Referring to FIGS. 9 and 10, another example device 700 in accordancewith some embodiments provided herein is illustrated. Device 700includes a body 703 that defines a lumen 705. Body 703 includes a firstend 707 and a second end 709. Body 703 has an external surface 710 and alumenal surface 712.

Device 700 can be constructed using any of the materials and techniquesas described herein in reference to device 1. Also, device 700 can beconfigured and used in any of the manners described herein in referenceto device 1.

In the depicted embodiment, first end 707 is beveled in relation to thelongitudinal surfaces of external surface 710. Second end 709 of thedepicted embodiment is also beveled in relation to the longitudinalsurfaces of external surface 710. It should be understood that, in someembodiments of device 700 (and the other devices provided herein), bothends 707 and 709 may be beveled (e.g., as shown), both ends 707 and 709may be orthogonal, or either one of ends 707 or 709 may be beveled whilethe other one of ends 707 or 709 is orthogonal.

In the depicted embodiment, lumen 705 includes a plurality of ovularpillars 713 that are spaced apart from each other. It should beunderstood that lumen 705 may be configured with any of the lumenalconstructs provided herein (e.g., FIGS. 15-26, and others), andcombinations thereof.

In the depicted embodiment, second end 709 includes a first flangeportion 714 a and a second flange portion 714 b. In someimplementations, flange portions 714 a and 714 b contact the surface ofthe cornea and provide mechanical stabilization of device 700 inrelation to the eye. The outer lateral surfaces of flange portions 714 aand 714 b include planar and chamfered portions in the depictedembodiment. In some embodiments, the outer lateral surfaces of flangeportions 714 a and 714 b are radiused (contoured) in relation to thelongitudinal surfaces of external surface 710.

In some embodiments, one or more suture attachment features are includedon device 700 (and the other devices provided herein). In the depictedembodiment, second end 709 includes a suture attachment structure 716.The suture attachment structure 716 is a slot in the depictedembodiment. In some embodiments, other types of suture attachmentstructures can be alternatively or additionally included. While thedepicted embodiment includes one suture attachment structure 716, insome embodiments, zero, two, three, four, or more than four sutureattachment structures are included.

One or more portions of external surface 710 can be configured forenhanced friction with eye tissue (e.g., the cornea or sclera). Suchportions can provide advantageous mechanical stability and/or migrationresistance of the device 700 (and the other devices provided herein) inrelation to the eye. For example, in the depicted embodiment, a surfaceportion 718 includes an enhanced texture (roughness) in comparison toother portions of external surface 710. In the depicted embodiment,surface portion 718 is a stippled surface. In some embodiments, othertypes of texturing configurations can be alternatively or additionallyincluded. For example, such texturing configurations can include, butare not limited to, cross-hatching, knurling, inclusion of one or morebarbs, and the like, and combinations thereof. In some embodiments, thesurface portion 718 is created by techniques such as, but not limitedto, laser machining, chemical etching, 3D printing, photo etching, andthe like.

Referring to FIGS. 11 and 12, another example device 800 in accordancewith some embodiments provided herein is illustrated. Device 800includes a body 803 that defines a lumen 805. Body 803 includes a firstend 807 and a second end 809. Body 803 has an external surface 810 and alumenal surface 812.

Device 800 can be constructed using any of the materials and techniquesas described herein in reference to device 1. Also, device 800 can beconfigured and used in any of the manners described herein in referenceto device 1.

In the depicted embodiment, first end 807 is beveled. Second end 809 ofthe depicted embodiment is also beveled in relation to the longitudinalsurfaces of external surface 810. It should be understood that, in someembodiments of device 800 and the other devices provided herein, bothends 807 and 809 may be orthogonal in relation to the longitudinalsurfaces of external surface 810, or either one of ends 807 or 809 maybe beveled while the other one of ends 807 or 809 is orthogonal.

In the depicted embodiment, lumen 805 includes a longitudinal rib 813.While in the depicted embodiment, the rib 813 extends continuously fromfirst end 807 to second end 809, in some embodiments, rib 813 may bemade of multiple individually shorter segments and/or otherarrangements. It should be understood that lumen 805 may be configuredwith any of the lumenal constructs provided herein (e.g., FIGS. 15-26,and others), and combinations thereof.

In the depicted embodiment, second end 809 includes a first flangeportion 814 a and a second flange portion 814 b. In someimplementations, one or more surfaces of flange portions 814 a and 814 bcontact the surface of the cornea and provide mechanical stabilizationof device 800 in relation to the eye. The outer lateral surfaces offlange portions 814 a and 814 b are planar and parallel to thelongitudinal surfaces of external surface 810 in the depictedembodiment. In some embodiments, the outer lateral surfaces of flangeportions 814 a and 814 b are contoured. In some embodiments, the outerlateral surfaces of flange portions 814 a and 814 b are planar andunparallel or askew in relation to the longitudinal surfaces of externalsurface 810.

In some embodiments, one or more suture attachment features are includedon device 800 (and the other devices provided herein). In the depictedembodiment, second end 809 includes a first suture attachment structure816 a and a second suture attachment structure 816 b. The sutureattachment structures 816 a and 816 b are holes in the depictedembodiment. In some embodiments, other types of suture attachmentstructures can be alternatively or additionally included. While thedepicted embodiment includes two suture attachment structures 816 a and816 b, in some embodiments, zero, one, three, four, or more than foursuture attachment structures are included.

One or more portions of external surface 810 can be configured forenhanced friction with eye tissue (e.g., the cornea or sclera).Advantageous mechanical stability and/or migration resistance of thedevice 800 (and the other devices provided herein) in relation to theeye can be facilitated by such portions. For example, in the depictedembodiment, a plurality of protrusions 818 provide an enhanced texture(greater roughness) in comparison to other portions of external surface810. In the depicted embodiment, protrusions 818 are disposed onopposing surfaces of external surface 810. It should be understood thatprotrusions 818 can be located in any desired location(s) on externalsurface 810. In some embodiments, other types of texturingconfigurations can be alternatively or additionally included. Forexample, such texturing configurations can include, but are not limitedto, cross-hatching, stippling, knurling, inclusion of one or more barbs,and the like, and combinations thereof. In some embodiments, the surfaceportion 818 is created by techniques such as, but not limited to, lasermachining, chemical etching, 3D printing, photo etching, and the like.

Referring to FIGS. 13 and 14, another example device 900 in accordancewith some embodiments provided herein is illustrated. Device 900includes a body 903 that defines a lumen 905. Body 903 includes a firstend 907 and a second end 909. Body 903 has an external surface 910 and alumenal surface 912.

Device 900 can be constructed using any of the materials and techniquesas described herein in reference to device 1. Also, device 900 can beconfigured and used in any of the manners described herein in referenceto device 1.

In the depicted embodiment, first end 907 is not beveled. Rather, firstend 907 is generally orthogonal in relation to the longitudinal surfacesof external surface 910. Second end 909 of the depicted embodiment isbeveled in relation to the longitudinal surfaces of external surface910. It should be understood that, in some embodiments of device 900(and the other devices provided herein), both ends 907 and 909 may bebeveled (e.g., like second end 909), both ends 907 and 909 may beorthogonal (e.g., like first end 907), or either one of ends 907 or 909may be beveled while the other one of ends 907 or 909 is orthogonal.

In the depicted embodiment, lumen 905 includes a first longitudinal rib913 a and a second longitudinal rib 913 b. While in the depictedembodiment, the ribs 913 a and 913 b extend continuously from first end907 to second end 909, in some embodiments, ribs 913 a and 913 b may bemade of multiple individually shorter segments and/or otherarrangements. It should be understood that lumen 905 may be configuredwith any of the lumenal constructs provided herein (e.g., FIGS. 15-26,and others), and combinations thereof.

In the depicted embodiment, second end 909 includes a first flangeportion 914 a and a second flange portion 914 b. In someimplementations, flange portions 914 a and 914 b contact the surface ofthe cornea and provide mechanical stabilization of device 900 inrelation to the eye. The outer lateral surfaces of flange portions 914 aand 914 b are planar and parallel to the longitudinal surfaces ofexternal surface 910 in the depicted embodiment. In some embodiments,the outer lateral surfaces of flange portions 914 a and 914 b arenonplanar (e.g., radiused, chamfered, contoured, etc.). In someembodiments, the outer lateral surfaces of flange portions 914 a and 914b are planar and unparallel or askew in relation to the longitudinalsurfaces of external surface 910.

In some embodiments, one or more suture attachment features are includedon device 900 (and the other devices provided herein). In the depictedembodiment, second end 909 includes a first suture attachment structure916 a and a second suture attachment structure 916 b. The sutureattachment structures 916 a and 916 b are slots in the depictedembodiment. In some embodiments, other types of suture attachmentstructures can be alternatively or additionally included. While thedepicted embodiment includes two suture attachment structures 916 a and916 b, in some embodiments, zero, one, three, four, or more than foursuture attachment structures are included.

One or more portions of external surface 910 can be configured forenhanced friction with eye tissue (e.g., the cornea or sclera).Advantageous mechanical stability and/or migration resistance of thedevice 900 (and the other devices provided herein) in relation to theeye can be facilitated by such portions. For example, in the depictedembodiment, one or more lateral barbs 918 are included on opposingsurfaces of external surface 910. In the depicted embodiment, lateralbarbs 918 are triangular protrusions with atraumatic tips (e.g.,truncated tips, radiused tips, and the like). In some embodiments, nosuch lateral barbs 918 are included. In some embodiments, other types oftexturing configurations can be alternatively or additionally included.For example, such texturing configurations can include, but are notlimited to, stippling, knurling, cross-hatching, and the like, andcombinations thereof. In some embodiments, the surface portion 918 iscreated by techniques such as, but not limited to, laser machining,chemical etching, 3D printing, photo etching, and the like.

FIGS. 15-26 depict various example lumenal structures that can beincorporated in the devices provided herein. It should be understoodthat the lumenal structures depicted are not an exhaustive compilationof structures that can be used for configuring the lumenal passagewaysof the devices provided herein. Moreover, the features of one or more ofthe depicted lumenal structures can be combined with the features of oneor more other depicted lumenal structures to create many differentcombinations, which are within the scope of this disclosure.

The example lumenal structures can be sized and configured to provide anappropriate outflow resistance to modulate aqueous humor flowing throughthe lumen without the need for an element that provides additional flowresistance (e.g., a filter or a porous element). In doing so, the lumenfunctions to maintain a desired IOP to treat a glaucoma afflicted eye,while also providing moisture and lubrication to the surface of eye andtear film. In some embodiments, a filter or filter-like porous elementis included in the devices provided herein.

Referring to FIG. 15, an example device 1000 can include a lumenalstructure 1005 that includes one or more longitudinal ribs 1013. In thedepicted embodiment, eight longitudinal ribs 1013 are included. In someembodiments, zero, one, two, three, four, five, six, seven, nine, ten,eleven, twelve, or more than twelve longitudinal ribs 1013 are included.Such longitudinal ribs 1013 serve to divide overall lumen 1005 into twoor more longitudinal portions.

Referring to FIG. 16, an example device 1100 can include a lumenalstructure 1105 that includes one or more longitudinal rib portions 1113.Such longitudinal rib portions 1113 serve to divide overall lumen 1105into some segments having two or more longitudinal portions, and somesegments that are undivided by longitudinal rib portions 1113. In thedepicted embodiment, eight longitudinal rib portions 1113 are included.In some embodiments, zero, one, two, three, four, five, six, seven,nine, ten, eleven, twelve, or more than twelve longitudinal rib portions1113 are included. Any suitable number of groupings of longitudinal ribportions 1113 can be included.

Referring to FIG. 17, an example device 1200 can include a lumenalstructure 1205 that includes one or more longitudinal rib portions 1213.Such longitudinal rib portions 1213 serve to divide overall lumen 1205into some segments having two or more longitudinal portions, and somesegments that are undivided by longitudinal rib portions 1213. Inaddition, in the depicted embodiment, alternating groupings oflongitudinal rib portions 1213 are laterally offset from adjacentgroupings of longitudinal rib portions 1213. In the depicted embodiment,eight longitudinal rib portions 1213 are included. In some embodiments,zero, one, two, three, four, five, six, seven, nine, ten, eleven,twelve, or more than twelve longitudinal rib portions 1213 are included.Any suitable number of groupings of longitudinal rib portions 1213 canbe included.

Referring to FIG. 18, an example device 1300 can include a lumenalstructure 1305 that includes one or more longitudinal ribs 1313. In thedepicted embodiment, six longitudinal ribs 1313 are included. In someembodiments, zero, one, two, three, four, five, seven, eight, nine, ten,eleven, twelve, or more than twelve longitudinal ribs 1313 are included.Such longitudinal ribs 1313 serve to divide overall lumen 1305 into twoor more longitudinal portions. Longitudinal ribs 1313 can be made tohave any suitable width.

Referring to FIG. 19, an example device 1400 can include a lumenalstructure 1405 that includes one or more longitudinal rib portions 1413.Such longitudinal rib portions 1413 serve to divide overall lumen 1405into some segments having two or more longitudinal portions, and somesegments that are undivided by longitudinal rib portions 1413. In thedepicted embodiment, six longitudinal rib portions 1413 are included. Insome embodiments, zero, one, two, three, four, five, seven, eight, nine,ten, eleven, twelve, or more than twelve longitudinal rib portions 1413are included. Any suitable number of groupings of longitudinal ribportions 1413 can be included. Longitudinal ribs 1313 can be made tohave any suitable width.

Referring to FIG. 20, an example device 1500 can include a lumenalstructure 1505 that includes one or more longitudinal rib portions 1513.Such longitudinal rib portions 1513 serve to divide overall lumen 1505into some segments having two or more longitudinal portions, and somesegments that are undivided by longitudinal rib portions 1513. Inaddition, in the depicted embodiment, alternating groupings oflongitudinal rib portions 1513 are laterally offset from adjacentgroupings of longitudinal rib portions 1513. In the depicted embodiment,six longitudinal rib portions 1513 are included. In some embodiments,zero, one, two, three, four, five, seven, nine, eight, ten, eleven,twelve, or more than twelve longitudinal rib portions 1513 are included.Any suitable number of groupings of longitudinal rib portions 1513 canbe included. Longitudinal ribs 1313 can be made to have any suitablewidth.

Referring to FIG. 21, an example device 1600 can include a lumenalstructure 1605 that includes one or more longitudinal ribs 1613. In thedepicted embodiment, three longitudinal ribs 1613 are included. In someembodiments, zero, one, two, four, five, six, seven, eight, nine, ten,eleven, twelve, or more than twelve longitudinal ribs 1613 are included.Such longitudinal ribs 1613 serve to divide overall lumen 1605 into twoor more longitudinal portions. Longitudinal ribs 1613 can be made tohave any suitable width.

Referring to FIG. 22, an example device 1700 can include a lumenalstructure 1705 that includes one or more longitudinal rib portions 1713.Such longitudinal rib portions 1713 serve to divide overall lumen 1705into some segments having two or more longitudinal portions, and somesegments that are undivided by longitudinal rib portions 1713. In thedepicted embodiment, three longitudinal rib portions 1713 are included.In some embodiments, zero, one, two, four, five, six, seven, eight,nine, ten, eleven, twelve, or more than twelve longitudinal rib portions1713 are included. Any suitable number of groupings of longitudinal ribportions 1713 can be included. Longitudinal ribs 1713 can be made tohave any suitable width.

Referring to FIG. 23, an example device 1800 can include a lumenalstructure 1805 that includes one or more longitudinal rib portions 1813.Such longitudinal rib portions 1813 serve to divide overall lumen 1805into some segments having two or more longitudinal portions, and somesegments that are undivided by longitudinal rib portions 1813. Inaddition, in the depicted embodiment, alternating groupings oflongitudinal rib portions 1813 are laterally offset from adjacentgroupings of longitudinal rib portions 1813. In the depicted embodiment,three longitudinal rib portions 1813 are included. In some embodiments,zero, one, two, four, five, six, seven, nine, eight, ten, eleven,twelve, or more than twelve longitudinal rib portions 1813 are included.Any suitable number of groupings of longitudinal rib portions 1813 canbe included. Longitudinal ribs 1313 can be made to have any suitablewidth.

Referring to FIG. 21, an example device 1900 can include a lumenalstructure 1905 that includes a plurality of circular pillars 1913. Suchcircular pillars 1913 serve to constrict lumen 1905 but not prevent allflow of fluid through lumen 1905. Circular pillars 1913 can be made tohave any suitable size (e.g., diameter). In the depicted embodiment,circular pillars 1913 are longitudinally aligned in rows.

Referring to FIG. 22, an example device 2000 can include a lumenalstructure 2005 that includes a plurality of circular pillars 2013. Suchcircular pillars 2013 serve to constrict lumen 2005 but not prevent allflow of fluid through lumen 2005. Circular pillars 2013 can be made tohave any suitable size (e.g., diameter). In the depicted embodiment,circular pillars 2013 are laterally offset from longitudinally adjacentcircular pillars 2013.

Referring to FIG. 23, an example device 2100 can include a lumenalstructure 2105 that includes a plurality of ovular pillars 2113. Suchovular pillars 2113 serve to constrict lumen 2105 but not prevent allflow of fluid through lumen 2105. Ovular pillars 2113 can be made tohave any suitable size (e.g., length and width). In the depictedembodiment, ovular pillars 2113 are laterally offset from longitudinallyadjacent ovular pillars 2113.

Referring to FIGS. 27 and 28, another example device 2200 in accordancewith some embodiments provided herein is illustrated. Device 2200includes a body 2203 that defines a lumen 2205. Body 2203 includes afirst end 2207 and a second end 2209. Body 2203 has an external surface2210, and a lumenal surface 2212. Device 2200 also includes a bolsterportion 2204. Bolster portion 2204 can be mated with body 2203. In somecases, second end 2209 of body 2203 can be coupled with receptacle 2218of bolster portion 2204. In some embodiments, a compression fit(interference fit) exists between body 2203 and bolster portion 2204,such that body 2203 and bolster portion 2204 are held together andeffectively function as a monolithic device prior to and afterimplantation into an eye.

Bolster portion 2204 and body 2203 can be constructed using any of thematerials and techniques as described herein in reference to device 1.In addition, in some embodiments, bolster portion 2204, or portionsthereof, is made of silicone. In some embodiments, bolster portion 2204,or portions thereof, is made of PET. Device 2200 can be configured andused in any of the manners described herein in reference to device 1.

Bolster portion 2204 provides a stable footing for device 2200 whendevice 2200 is implanted in an eye. In some cases, at least a portion ofbolster portion 2204 contacts the surface of the eye, therebymechanically stabilizing the device 2200 in relation to the eye. In somecases, bolster portion 2204 can serve to prevent or inhibit tipping ofdevice 2200 in relation to the eye. Other device design features anddevice use techniques to prevent or inhibit tipping of device 2200 (andthe other devices provided herein) in relation to the eye are alsoenvisioned. For example, the inclusion of design features such as barbs,textured surfaces, projections, and other mechanical aspects can beincluded to prevent or inhibit tipping. Further, in some cases the angleof insertion of the device 200 (and the other devices provided herein)can be selected and/or optimized so prevent or inhibit tipping.

While in the depicted embodiment, bolster portion 2204 is rectangular,in some embodiments, bolster portions with other shapes are used. Suchshapes can include, but are not limited to, circles, ovals, squares,parallelograms, and the like. Bolster portion 2219 can be oriented at anangle 2219 in relation to body 2203. In some embodiments, angle 2219 isabout a 45° angle. In some embodiments, angle 2219 is within the rangefrom about 40° to about 50°, or from about 35° to about 45°, or fromabout 45° to about 55°, or from about 30° to about 60°, or from about20° to about 70°, or from about 10° to about 80°, or from about 0° toabout 90°, or greater than about 90°.

In the depicted embodiment, first end 2207 is beveled. In someembodiments, first end 2207 is generally orthogonal in relation to thelongitudinal surfaces of external surface 2210. Second end 2209 of thedepicted embodiment is not beveled in relation to the longitudinalsurfaces of external surface 2210. It should be understood that, in someembodiments of device 2200 and the other devices provided herein, bothends 2207 and 2209 may be beveled (e.g., like first end 2207), both ends2207 and 2209 may be orthogonal (e.g., like second end 2209), or eitherone of ends 2207 or 2209 may be beveled while the other one of ends 2207or 2209 is orthogonal.

In the depicted embodiment, second end 2209 extends beyond bolsterportion 2204. In some embodiments, second end 2209 is flush or slightlyrecessed in relation to bolster portion 2204.

In the depicted embodiment, lumen 2205 includes a longitudinal rib 2213.While in the depicted embodiment, rib 2213 extends continuously fromfirst end 2207 to second end 2209, in some embodiments, rib 2213 may bemade of multiple individually shorter segments and/or otherarrangements. It should be understood that lumen 2205 may be configuredwith any of the lumenal constructs provided herein (e.g., FIGS. 15-26,and others), and combinations thereof.

In the depicted embodiment, second end 2209 includes a first flangeportion 2214 a and a second flange portion 2214 b. In someimplementations, flange portions 2214 a and 2214 b contact the surfaceof the cornea and provide mechanical stabilization of device 2200 inrelation to the eye. In addition, in this two-piece construct of device2200, flange portions 2214 a and 2214 b engage within recesses ofbolster portion 2204 to provide a sturdy mechanical connectiontherebetween. In the depicted embodiment, flange portions 2214 a and2214 b protrude from bolster portion 2204. In some embodiments, flangeportions 2214 a and 2214 b are flush or slightly recessed in relation tobolster portion 2204.

In some embodiments, one or more suture attachment features are includedon device 2200 (and the other devices provided herein). In the depictedembodiment, bolster portion 2204 includes a first suture attachmentstructure 2216 a and a second suture attachment structure 2216 b. Thesuture attachment structures 2216 a and 2216 b are holes in the depictedembodiment. In some embodiments, other types of suture attachmentstructures can be alternatively or additionally included. While thedepicted embodiment includes two suture attachment structures 2216 a and2216 b, in some embodiments, zero, one, three, four, or more than foursuture attachment structures are included.

One or more portions of external surface 2210 can be configured forenhanced friction with eye tissue (e.g., the cornea or sclera) toimprove mechanical stability and/or migration resistance of the device2200 (and the other devices provided herein) in relation to the eye. Insome embodiments, configurations of external surface 2210 can include,but are not limited to, stippling, knurling, cross-hatching, inclusionof one or more barbs, and the like, and combinations thereof. In someembodiments, some such configurations are created by techniques such as,but not limited to, laser machining, chemical etching, 3D printing,photo etching, and the like.

Referring to FIGS. 29 and 30, another example device 2300 in accordancewith some embodiments provided herein is illustrated. Device 2300includes a body 2303 that defines a lumen 2305. Body 2303 includes afirst end 2307 and a second end 2309. Body 2303 has an external surface2310 and a lumenal surface 2312. Device 2300 also includes a bolsterportion 2304. Bolster portion 2304 can be mated with body 2303. In somecases, body 2303 can be coupled with receptacle 2318 of bolster portion2304 such that flange portions 2314 a and 2314 b are positioned incontact with bolster portion 2304. In some embodiments, a compressionfit (interference fit) exists between body 2303 and bolster portion2304, such that body 2303 and bolster portion 2304 are held together andeffectively function as a monolithic device prior to and afterimplantation into an eye.

Bolster portion 2304 and body 2303 can be constructed using any of thematerials and techniques as described herein in reference to device 1.In addition, in some embodiments, bolster portion 2304, or portionsthereof, is made of silicone. In some embodiments, bolster portion 2304,or portions thereof, is made of PET. Device 2300 can be configured andused in any of the manners described herein in reference to device 1.

Bolster portion 2304 provides a stable footing for device 2300 whendevice 2300 is implanted in an eye. In some cases, at least a portion ofbolster portion 2304 contacts the surface of the eye, therebymechanically stabilizing the device 2300 in relation to the eye. In somecases, bolster portion 2304 can serve to prevent or inhibit tipping ofdevice 2300 in relation to the eye.

While in the depicted embodiment, bolster portion 2304 is ovular, insome embodiments, bolster portions with other shapes are used. Suchshapes can include, but are not limited to, circles, rectangles,squares, parallelograms, and the like. Bolster portion 2319 can beoriented at an angle 2319 in relation to body 2303. In some embodiments,angle 2319 is about a 45° angle. In some embodiments, angle 2319 iswithin the range from about 40° to about 50°, or from about 35° to about45°, or from about 45° to about 55°, or from about 30° to about 60°, orfrom about 20° to about 70°, or from about 10° to about 80°, or fromabout 0° to about 90°, or greater than about 90°.

In the depicted embodiment, first end 2307 is not beveled. Rather, firstend 2307 is generally orthogonal in relation to the longitudinalsurfaces of external surface 2310. Second end 2309 of the depictedembodiment is also not beveled in relation to the longitudinal surfacesof external surface 2310. It should be understood that, in someembodiments of device 2300 and the other devices provided herein, bothends 2307 and 2309 may be beveled, both ends 2307 and 2309 may beorthogonal, or either one of ends 2307 or 2309 may be beveled while theother one of ends 2307 or 2309 is orthogonal.

In the depicted embodiment, second end 2309 extends beyond bolsterportion 2304. In some embodiments, second end 2309 is flush or slightlyrecessed in relation to bolster portion 2304.

In the depicted embodiment, lumen 2305 includes a longitudinal rib 2313.While in the depicted embodiment, rib 2313 extends continuously fromfirst end 2307 to second end 2309, in some embodiments, rib 2313 may bemade of multiple individually shorter segments and/or otherarrangements. It should be understood that lumen 2305 may be configuredwith any of the lumenal constructs provided herein (e.g., FIGS. 15-26,and others), and combinations thereof.

In the depicted embodiment, second end 2309 includes first flangeportion 2314 a and second flange portion 2314 b. In this two-piececonstruct of device 2300, flange portions 2314 a and 2314 b engage withbolster portion 2304 to provide a sturdy mechanical connectiontherebetween. In the depicted embodiment, flange portions 2314 a and2314 b protrude from bolster portion 2304. In some embodiments, flangeportions 2314 a and 2314 b are flush or slightly recessed in relation tobolster portion 2304.

In some embodiments, one or more suture attachment features are includedon device 2300 (and the other devices provided herein). In the depictedembodiment, bolster portion 2304 does not include any such sutureattachment features. In some embodiments, when bolster portion 2304 ismade of silicone, bolster portion 2304 can be pierced by a needle toallow sutures to be threaded through bolster portion 2304 (despite thelack of specific suture attachment features). While the depictedembodiment includes no suture attachment structures, in someembodiments, one, two, three, four, or more than four suture attachmentstructures are included.

One or more portions of external surface 2310 can be configured forenhanced friction with eye tissue (e.g., the cornea or sclera) toimprove mechanical stability and/or migration resistance of the device2300 (and the other devices provided herein) in relation to the eye. Insome embodiments, configurations of external surface 2310 can include,but are not limited to, stippling, knurling, cross-hatching, inclusionof one or more barbs, and the like, and combinations thereof. In someembodiments, some such configurations are created by techniques such as,but not limited to, laser machining, chemical etching, 3D printing,photo etching, and the like.

Referring to FIG. 31, an example device 2400 is shown implanted inafflicted eye 20 for the purpose of treating glaucoma of afflicted eye20. The depicted anatomical features of eye 20 include anterior chamber2, sclera 6, tear film 4, iris 23, ciliary body 25, and cornea 21.

Device 2400 includes body 2403 that defines lumen 2405. Body 2403includes first end 2407 and a second end 2409. Body 2403 has an externalsurface 2410, and a lumenal surface 2412.

In the depicted embodiment, device 2400 also includes a longitudinalextension member 2420 that is attached to body 2403. An anchor member2422 is attached to the opposite end of the extension member 2420.Anchor member 2422 can be a structure such as, but not limited to, abarb, a hook, a screw, a clamp, and the like. Anchor member 2422 can beimplanted within or attached to cornea 21 or sclera 6. In some cases,extension member 2420 and anchor member 2422 serve to stabilizemechanically device 2400 in relation to eye 20.

In some embodiments, extension member 2420 is a wire member, or anothertype of elongate member. In some embodiments, extension member 2420 andanchor member 2422 are made of a metallic material such as nitinol orstainless steel. Alternatively or additionally, in some embodiments,extension member 2420 and anchor member 2422 are made of a polymericmaterial.

Referring to FIG. 32, another example device 2500 in accordance withsome embodiments provided herein is illustrated. Device 2500 includes abody 2503 that defines a lumen 2505. Body 2503 includes a first end 2507and a second end 2509. Body 2503 has an external surface 2510 and alumenal surface 2512.

Device 2500 can be constructed using any of the materials and techniquesas described herein in reference to device 1. Also, device 2500 can beconfigured and used in any of the manners described herein in referenceto device 1.

In the depicted embodiment, first end 2507 is beveled. In someembodiments, first end 2507 is generally orthogonal in relation to thelongitudinal surfaces of external surface 2510. Second end 2509 of thedepicted embodiment is not beveled in relation to the longitudinalsurfaces of external surface 2510. It should be understood that, in someembodiments of device 2500 and the other devices provided herein, bothends 2507 and 2509 may be beveled (e.g., like first end 2507), both ends2507 and 2509 may be orthogonal (e.g., like second end 2509), or eitherone of ends 2507 or 2509 may be beveled while the other one of ends 2507or 2509 is orthogonal.

In the depicted embodiment, lumen 2505 is open continuously from firstend 2507 to second end 2509. In some embodiments, lumen 2505 can beconfigured with any of the other lumenal constructs provided herein(e.g., FIGS. 15-26, and others), and combinations thereof.

In the depicted embodiment, second end 2509 includes a first flangeportion 2514 a and a second flange portion 2514 b. In someimplementations, flange portions 2514 a and 2514 b contact the surfaceof the cornea and provide mechanical stabilization of device 2500 inrelation to the eye. The outer lateral surfaces of flange portions 2514a and 2514 b are radiused (contoured) in the depicted embodiment. Insome embodiments, the outer lateral surfaces of flange portions 2514 aand 2514 b are planar and parallel to the longitudinal surfaces ofexternal surface 2510. In some embodiments, the outer lateral surfacesof flange portions 2514 a and 2514 b are planar and unparallel or askewin relation to the longitudinal surfaces of external surface 2510.

In some embodiments, one or more suture attachment features are includedon device 2500 (and the other devices provided herein). In the depictedembodiment, second end 2509 includes a first suture attachment structure2516 a and a second suture attachment structure 2516 b. The sutureattachment structures 2516 a and 2516 b are grooves in the depictedembodiment. In some embodiments, other types of suture attachmentstructures can be alternatively or additionally included. While thedepicted embodiment includes two suture attachment structures 2516 a and2516 b, in some embodiments, zero, one, three, four, or more than foursuture attachment structures are included.

One or more portions of external surface 2510 can be configured forenhanced friction with eye tissue (e.g., the cornea or sclera).Advantageous mechanical stability and/or migration resistance of thedevice 2500 (and the other devices provided herein) in relation to theeye can be facilitated by such portions. For example, in the depictedembodiment, a surface portion 2518 includes an enhanced texture(roughness) in comparison to other portions of external surface 2510. Inthe depicted embodiment, surface portion 2518 is a stippled surface. Insome embodiments, other types of texturing configurations can bealternatively or additionally included. For example, such texturingconfigurations can include, but are not limited to, cross-hatching,knurling, inclusion of one or more barbs, and the like, and combinationsthereof. In some embodiments, the surface portion 2518 is created bytechniques such as, but not limited to, laser machining, chemicaletching, 3D printing, photo etching, and the like.

Referring to FIG. 33, another example device 2600 in accordance withsome embodiments provided herein is illustrated. Device 2600 includes abody 2603 that defines a lumen 2605. Body 2603 includes a first end 2607and a second end 2609. Body 2603 has an external surface 2610, and alumenal surface 2612.

Device 2600 can be constructed using any of the materials and techniquesas described herein in reference to device 1. Also, device 2600 can beconfigured and used in any of the manners described herein in referenceto device 1.

In the depicted embodiment, device 2600 is generally configured in thearrangement as device 2500 of FIG. 32. Device 2600 differs from device2500 in that second end 2609 is extended beyond flange portions 2614 aand 2614 b by a distance 2620. In some embodiments, distance 2620 isabout 300 μm. In some embodiments, distance 2620 is in a range fromabout 200 μm to about 400 μm, or from about 100 μm to about 500 μm, orfrom about 0 μm to about 600 μm.

Referring to FIG. 34, example devices 2700 and 2800 can be implanted inan eye 20 that is afflicted with glaucoma.

A second method for installing the devices provided herein is asfollows. Sometime before installation, the eye is irrigated with 1-5%Betadine solution, and topical antibiotic and non-steroidalanti-inflammatory drops (NSAID) are applied to the operative eye. Thesecan be continued for about one week postoperatively four times a day.The NSAID can help stabilize the blood-aqueous barrier. All embodimentsof the device illustrated herein may be inserted under topicalanesthesia, possibly supplemented subconjunctivally.

This insertion procedure can be conducted without excising conjunctivaat the site of the anticipated insertion. Approximately 1-2 mm posteriorto the limbus, a diamond blade can be used to make a stab incision intothe anterior chamber, while held roughly parallel to the iris. The bladecan be of a size predetermined to make an opening into the anteriorchamber sized appropriately for the introduction of the device. Thisstab incision can be made gently, but relatively quickly, assiduouslyavoiding any and all intraocular structures.

The device is next picked up and can be held with a non-toothed forceps.The lips of the stab incision wound may be gaped with a fine, toothedforceps. The distal end (which may or may not be a pointed/beveled tip)of the tube element would then be gently pushed through the scleraltract of the stab incision and into the anterior chamber, with thedevice lying above and parallel to the iris, with the bevel up (i.e.,anteriorly). The lateral flanges in the embodiments so configuredprovide for a definite endpoint to the depth of insertion. Forembodiments of the device having a beveled first end, the bevel isoriented anteriorly to minimize the potential for blockage of thelumenal opening by the iris. The scleral barb(s) or other outer surfacefeatures (if included) can stabilize the device until the biointegrationwith the sclera is complete. This biointegration is a function of itsporous cellular ingrowth surface, possibly enhanced by adsorbed growthfactors and/or grafted extracellular matrix proteins. In someimplementations, one or more sutures may be added using the device'ssuture attachment features to stabilize the device prior tobiointegration. For example, a 10-0 nylon suture on a broad spatulaneedle may be used to suture the device the sclera, providing additionalstability to the device until the biointegration is complete. Thissuture may then be easily removed at a later time if needed. Analternative insertion technique can include having the device pre-loadedinto an insertion holder or cartridge, to limit the needed handling ofthe device by the surgeon. A properly sized sharp blade could be at theleading edge of the inserter, such blade acting also as a guide forimplanting the device. Alternatively, the paracentesis can be made witha separate blade, followed by controlled insertion with an inserter.

After insertion of the device, an ocular shield can be placed over theeye. The implanted device can bio-integrate with the sclera, therebyreducing the risks of infections such as tunnel infection.

Referring to FIG. 35, eye 20 is shown after devices 2700 and 2800 havebeen implanted for a period of approximately two weeks. The end portionsof devices 2700 and 2800 have not been overgrown with conjunctivaltissue. Hence, the lumens of devices 2700 and 2800 are patent and canfunction to reduce IOP, thereby treating glaucoma in a safe andeffective manner.

Referring to FIG. 36, eye 20 is shown after devices 2700 and 2800 havebeen implanted for a period of approximately one month. The end portionsof devices 2700 and 2800 still have not been overgrown with conjunctivaltissue. Hence, the lumens of devices 2700 and 2800 are patent and canfunction to reduce IOP, thereby treating glaucoma in a safe andeffective manner. In addition, the photo shows that the prior irritation(redness) of the tissue has subsided. Hence, devices 2700 and 2800 havebeen successfully integrated by the patient in this example.

Prevention of conjunctival tissue overgrowth to sustain patency of thedevice's lumen has been found to be effected by a number of variousdesign factors such as, but not limited to, material selection,coatings, physical distance and geometry of the projection of the devicefrom the surface of the eye, and the angle of the projecting endrelative to the eye. For example, from animal experimentation, therelationships between time and projection distance (distance from theeye's surface to the end of the device) shown in Table 1 below have beenobserved.

TABLE 1 Amount of Conjunctival Overgrowth 1 Month Projection 1 Weekafter 2 Weeks after after 2 Months after Distance ImplantationImplantation Implantation Implantation 200 μm none partial full full 800μm none none none none

Referring to FIGS. 37 and 38, another example device for treatingglaucoma in accordance with the techniques provided herein is atwo-piece device 2900. Two-piece device 2900 includes a collar 2910 anda cartridge 2940. Collar 2910 is configured to slidably receivecartridge 2940, such that collar 2910 and cartridge 2940 are releasablycoupleable.

During normal use, collar 2910 and cartridge 2940 are coupled together(as shown in FIG. 38). In that coupled arrangement, two-piece device2900 can be implanted in a sclera of an afflicted eye to allow aqueoushumor to flow from the anterior chamber of the afflicted eye throughtwo-piece device 2900, and into the tear film (as shown in FIG. 39).This outflow of aqueous humor into the tear film can treat glaucoma byreducing the intraocular pressure of the afflicted eye, in addition toproviding moisture and lubrication to the surface of the eye. Suchfunctionality is consistent with that of other device embodimentsdescribed herein.

Along with the ability to reduce intraocular pressure, two-piece device2900 provides added functional advantages related to the fact thatcollar 2910 and cartridge 2940 are releasably coupleable. For example,as described further herein, while collar 2910 remains implanted in thesclera of an afflicted eye, a used cartridge 2940 can be removed fromengagement with the implanted collar 2910, and a new cartridge 2940 canbe reinstalled into the implanted collar 2910. In some cases, such aprocedure for installing a new cartridge 2940 is not as extensive aswould be the procedure for installing an entire new single piece device.Hence, two-piece device 2900 can in some cases provide functionaladvantages related to the fact that collar 2910 and cartridge 2940 arereleasably coupleable.

Collar 2910 and cartridge 2940 can be constructed using any of thematerials and techniques as described herein in reference to device 1and other devices provided herein. In addition, in some embodiments,collar 2910 and/or cartridge 2940, or portions thereof, are made ofsilicone. In some embodiments, collar 2910 and/or cartridge 2940, orportions thereof, are made of PET. Two-piece device 2900 can beconfigured and used in any of the manners described herein in referenceto device 1. In some cases, the inner and/or outer surfaces of thetwo-piece device 2900 can be coated with materials such as polymercoatings or biologically active molecules, to promote surfacebiocompatibility and/or immobilization of the implanted device.

Collar 2910 includes a body 2912. In the depicted embodiment, body 2912includes barbs 2912 a and 2912 b. One or more portions of body 2912 canbe configured for enhanced friction with eye tissue (e.g., the cornea orsclera). Advantageous mechanical stability and/or migration resistanceof the device two-piece 2900 (and the other devices provided herein) inrelation to the eye can be facilitated by such portions. For example, inthe depicted embodiment, one or more lateral barbs 2912 a and 2912 b areincluded on opposing surfaces of body 2912. In the depicted embodiment,lateral barbs 2912 a and 2912 b are triangular protrusions with sharptips. Other types of shapes may be used for lateral barbs 2912 a and2912 b. In some embodiments, lateral barbs 2912 a and 2912 b areconfigured to be atraumatic (e.g., truncated tips, radiused tips, andthe like). In some embodiments, multiple barbs are used on one or moreparticular surfaces of body 2912. In some embodiments, no such lateralbarbs 2912 a and 2912 b are included. The barbs 2912 a and 2912 b may beformed as part of body 2912 during manufacture, or may be fused orbonded to body 2912 using any appropriate technique.

In the depicted embodiment, a surface portion 2918 of body 2912 includesan enhanced texture (roughness) in comparison to other surface portionsof body 2912. In the depicted embodiment, surface portion 2918 is across-hatched surface. In some embodiments, other types of texturingconfigurations can be alternatively or additionally included. Forexample, such texturing configurations can include, but are not limitedto, stippling, knurling, inclusion of one or more barbs, and the like,and combinations thereof. In some embodiments, the surface portion 2918is created by techniques such as, but not limited to, laser machining,chemical etching, 3D printing, photo etching, and the like. Suchtexturing can be located on all external surfaces of body 2912 in someembodiments. In specific embodiments, texturing may be located on someexternal surfaces of body 2912, but not on others. In some embodiments,no such texturing is included on any external surfaces of body 2912.

Body 2912 defines a lumen 2914. Lumen 2914 can extend entirely throughbody 2912 from a proximal end to a distal end of body 2912. In someembodiments, lumen 2914 is sized for press-fit coupling with cartridge2940. That is, in some embodiments a dimensional interference betweenthe sizes of lumen 2914 and cartridge 2940 may facilitate a mechanicalcoupling therebetween. Alternatively, or additionally, in someembodiments other mechanical coupling techniques between body 2914 andcartridge 2940 can be used. Such techniques can include, but are notlimited to, use of adhesives, snap-fitting, use of welding techniques,threading, clamping, and the like, and combinations thereof.

PEG can be used to define lumen 2914, in some embodiments. The use ofPEG for the surfaces of lumen 2914 can be advantageous because PEGresists bacterial, protein, and cell adherence. In some embodiments, lowmolecular weight PEG can be used. In some cases, the PEG isphoto-polymerized. In some cases, the PEG is not photo-polymerized.

In order to facilitate a desired coupling arrangement between cartridge2940 and lumen 2914, in some embodiments the outer dimensions ofcartridge 2940 are inconsistent along the longitudinal length ofcartridge 2940. For example, in some embodiments a distal portion ofcartridge 2940 has smaller outer dimensions than a proximal portion ofcartridge 2940. That way, when cartridge 2940 is inserted into lumen2914, the distal portion of cartridge 2940 will slide through lumen2914, while the proximal portion of cartridge 2940 will become coupledwith lumen 2914 due to a dimensional interference therebetween.

Cartridge 2940 includes a body 2943 that defines a lumen 2945. Body 2943includes a first end 2947 and a second end 2949. Body 2943 has anexternal surface 2210, and a lumenal surface 2212. Device 2200 alsoincludes a bolster portion 2204. Bolster portion 2204 can be mated withbody 2203. In some cases, second end 2209 of body 2203 can be coupledwith receptacle 2218 of bolster portion 2204.

In the depicted embodiment, lumen 2945 includes a longitudinal rib 2953.While in the depicted embodiment, rib 2953 extends continuously fromfirst end 2947 to second end 2949, in some embodiments, rib 2953 may bemade of multiple individually shorter segments and/or otherarrangements. It should be understood that lumen 2945 may be configuredwith any of the lumenal constructs provided herein (e.g., FIGS. 15-26,and others), and combinations thereof.

While in the depicted embodiment, the cross-sectional shapes of collar2910 and cartridge 2940 are rectangular, in some embodiments, othercross-sectional shapes are used. Such cross-sectional shapes caninclude, but are not limited to, circles, ovals, squares,parallelograms, and the like.

In the depicted embodiment, first end 2947 is not beveled. Rather, firstend 2947 is generally orthogonal in relation to the longitudinalexternal surfaces of body 2943. Second end 2949 of the depictedembodiment is beveled in relation to the longitudinal external surfacesof body 2943. It should be understood that, in some embodiments oftwo-piece device 2900 and the other devices provided herein, both ends2947 and 2949 may be beveled, both ends 2947 and 2949 may be orthogonal,or either one of ends 2947 and 2949 may be beveled while the other oneof ends 2947 and 2949 is orthogonal.

In the depicted embodiment, second end 2949 extends beyond collar 2910(in the coupled arrangement of FIG. 38). For example, in someembodiments second end 2949 extends beyond collar 2910 by about 200 μm.In some embodiments, second end 2949 extends beyond collar 2910 by adistance in a range from about 50 μm to about 1000 μm, or from about 50μm to about 200 μm, or from about 100 μm to about 300 μm, or from about200 μm to about 400 μm, or from about 300 μm to about 500 μm, or fromabout 400 μm to about 600 μm, or from about 500 μm to about 700 μm, orfrom about 600 μm to about 800 μm, or from about 700 μm to about 900 μm,or from about 800 μm to about 1,000 μm. In some embodiments, while inthe coupled arrangement, second end 2949 is flush or slightly recessedin relation to collar 2910.

In some embodiments, one or more suture attachment features areoptionally included on two-piece device 2900 (and the other devicesprovided herein). For example, in some embodiments suture attachmentfeatures may be included on collar 2910. The suture attachment featurescan be holes, slots, flanges, and the like, and combinations thereof inthe depicted embodiment.

Referring to FIG. 39, two-piece device 2900 is shown implanted in anafflicted eye 20 for the purpose of treating glaucoma of afflicted eye20. The depicted anatomical features of eye 20 include an anteriorchamber 2, a sclera 6, a tear film 4, an iris 23, a ciliary body 25, anda cornea 21. Two-piece device 2900 includes collar 2910 and cartridge2940. Cartridge 2940 includes first end 2947 and second end 2949.

As depicted, two-piece device 2900 is configured to be surgicallyimplanted in sclera 6 of eye 20. Two-piece device 2900 has a lengthsufficient to provide fluid communication between anterior chamber 2 andtear film 4 of eye 20 when two-piece device 2900 is implanted in sclera6. As described further herein, in some embodiments, lumen 2945 can besized and configured to provide an appropriate outflow resistance tomodulate aqueous humor flowing through lumen 2945, without an elementthat provides additional flow resistance (e.g., a filter or a porouselement). In doing so, lumen 2945 functions to maintain a desired TOP totreat a glaucoma-afflicted eye 20, while also providing moisture andlubrication to the surface of eye 20 and tear film 4. In other words,aqueous humor is shunted directly to tear film 4. No conjunctival blebis formed. Additionally, no EVP is created that could raise nocturnalIOP. Rather, EVP is unaffected. In some cases, lumen 2945 includes afilter or a porous element.

In some cases, collar 2910 can be implanted so that the proximal end ofcollar 2910 is generally flush with the outer surface of eye 20. Collar2910 can be configured with a length such that when generally flush withthe outer surface of eye 20, the distal end of collar 2910 extendsbeyond sclera 6, just into anterior chamber 2.

In some cases, to provide fluid communication between anterior chamber 2and tear film 4 (via lumen 2945), two-piece device 2900 has a totallength of about 2.5 mm. In some embodiments, two-piece device 2900 has atotal length of between about 2.5 mm and about 5.0 mm, or between about3.5 mm and about 6.0 mm. The length of at least about 2.5 mm will reducethe possibility of blockage of the lumenal opening in anterior chamber 2by iris 23. The length of two-piece device 2900 within the scleral tractwould preferably be greater than the scleral thickness, becauseinsertion would not be perpendicular to sclera 6 (but more tangential)to be parallel to iris 23.

As described in reference to FIGS. 37 and 38, two-piece device 2900 isconfigured such that cartridge 2940 can be removed from the collar 2910while collar 2910 remains implanted in sclera 6. Thereafter, a newcartridge 2940 can be readily installed in collar 2910. Such a featurecan be advantageous in various circumstances. In one examplecircumstance, over a period of time lumen 2945 of a used cartridge 2940may become partially or fully occluded by biomaterials, for example.Therefore, it may become desirable or necessary to remove used cartridge2940, and to install a new cartridge 2940. In such a case, a cliniciancan remove used cartridge 2940 (while leaving collar 2910 in itsimplanted position) and then install a new cartridge 2940 into a coupledarrangement with collar 2910.

In another example circumstance, two-piece device 2900 is configured tobe adaptable to a patient's needs over time by facilitating the use ofcartridges 2940 of differing flow resistances in accordance with thepatient's needs. For example, physicians can prescribe differentresistance levels if the patient needs more or less AH flow to treat thepatient's glaucoma. When a cartridge 2940 with a different resistancelevel is needed by the patient, the old cartridge 2940 can be removedand the new cartridge 2940 can be installed, using the advantageoustechniques (while leaving collar 2910 in its implanted position)accommodated by two-piece device 2900.

Referring to FIGS. 40 and 41, in some cases a deployment tool 3000 canbe used to assist in the implantation of the glaucoma treatment devicesprovided herein (such as the depicted example device 3100). The use ofdeployment tool 3000 can be advantageous because the minute size ofglaucoma treatment device 3100 can make glaucoma treatment device 3100otherwise challenging for a clinician to handle and manipulate as neededduring the implantation process.

Deployment tool 3000 includes a grasping portion 3010, a shaft 3020, anda distal end 3030 that is configured to releasably engage with device3100. In the depicted embodiment, distal end 3030 includes a slot 3032that is configured to releasably engage with a proximal end of device3100. For example, in some embodiments a light interference fit can beprovided between slot 3032 and proximal end of device 3100. In someembodiments, other releasable engagement techniques between distal end3030 and device 3100 can be used. For example, in some embodimentsdistal end 3030 can include retractable tabs that a clinician canretract after device 3100 has been implanted in the eye of a patient.Other releasable engagement techniques are also contemplated.

In some cases, an end user clinician may receive deployment tool 3000and device 3100 in a coupled arrangement, in a sterile package. Toperform the implant procedure, the clinician would remove the coupledcombination of deployment tool 300 and device 3100 from the sterilepackage, and use deployment tool to implant device 3100 in accordancewith the implant techniques described herein. When device 3100 isimplanted in the patient's eye as desired, the clinician can uncoupledeployment tool 3000 from implanted device 3100.

While this specification contains many specific implementation details,these should not be construed as limitations on the scope of anyinvention or of what may be claimed, but rather as descriptions offeatures that may be specific to particular embodiments of particularinventions. Certain features that are described in this specification inthe context of separate embodiments can also be implemented incombination in a single embodiment. Conversely, various features thatare described in the context of a single embodiment can also beimplemented in multiple embodiments separately or in any suitablesubcombination. Moreover, although features may be described herein asacting in certain combinations and even initially claimed as such, oneor more features from a claimed combination can in some cases be excisedfrom the combination, and the claimed combination may be directed to asubcombination or variation of a subcombination.

Similarly, while operations are depicted in the drawings in a particularorder, this should not be understood as requiring that such operationsbe performed in the particular order shown or in sequential order, orthat all illustrated operations be performed, to achieve desirableresults. In certain circumstances, multitasking and parallel processingmay be advantageous. Moreover, the separation of various system modulesand components in the embodiments described herein should not beunderstood as requiring such separation in all embodiments, and itshould be understood that the described program components and systemscan generally be integrated together in a single product or packagedinto multiple products.

Particular embodiments of the subject matter have been described. Otherembodiments are within the scope of the following claims. For example,the actions recited in the claims can be performed in a different orderand still achieve desirable results. As one example, the processesdepicted in the accompanying figures do not necessarily require theparticular order shown, or sequential order, to achieve desirableresults. In certain implementations, multitasking and parallelprocessing may be advantageous.

1. A device for treating glaucoma in an eye, the device comprising: abody defining a lumen and having first and second ends and external andlumenal surfaces, said body having a length sufficient to provide fluidcommunication between an anterior chamber and a tear film of the eyethrough said lumen when said device is implanted in a sclera of the eye,the body including a suture attachment feature configured for receivinga suture to attach the body to the eye. 2.-4. (canceled)
 5. The deviceof claim 1, wherein the second end is flared or laterally extended. 6.The device of claim 1, wherein the lumen is open from the first end tothe second end and configured to maintain a desired intraocular pressurewithout a porous element inside the lumen.
 7. The device of claim 1,wherein the body includes one or more ribs that extend longitudinallythrough at least a portion of the lumen, and wherein the one or moreribs define open channels for aqueous humor outflow.
 8. The device ofclaim 1, wherein the lumenal surface of the device comprises ahydrophilic material.
 9. The device of claim 8, wherein the hydrophilicmaterial comprises polyethylene glycol.
 10. The device of claim 1,wherein the external surface of the device is coated with ahetero-bifunctional crosslinker.
 11. The device of claim 10, wherein thehetero-bifunctional crosslinker is 5-azido-2-nitrobenzoic acidN-hydroxysuccinimide.
 12. The device of claim 1, wherein the externalsurface of the device is configured to provide increased friction withthe sclera.
 13. The device of claim 1, further comprising a bolsterportion configured to couple with the body, wherein the bolster portionis configured to stabilize the body in relation to the eye when saiddevice is implanted in the sclera of the eye.
 14. A method for treatingan eye, the method comprising: implanting a device in the sclera of theeye, wherein the device comprises: a body defining a lumen and havingfirst and second ends and external and lumenal surfaces, the bodyincluding a suture attachment feature configured for receiving a sutureto attach the body to the eye; and suturing the device to the eye usingthe suture attachment feature, wherein, while the device is implanted inthe sclera, aqueous humor flows from an anterior chamber of the eye tothe tear film of the eye through the lumen.
 15. The method of claim 14,wherein, after implanting the device, the second end protrudes from theeye by a distance in the range from about 50 μm to about 1000 μm. 16.The method of claim 15, wherein a portion of the second end is laterallyextended and a surface of the laterally extended portion is in contactwith the eye and generally follows a contour of the eye.
 17. The methodof claim 14, wherein the aqueous humor flowing from the anterior chamberto the tear film of the eye increases moisture and lubrication of asurface of the eye.
 18. A two-piece device for treating glaucoma in aneye, the device comprising: a collar defining a first lumentherethrough; and a cartridge, wherein at least a portion of thecartridge is releasably engageable within the first lumen, the cartridgedefining a second lumen therethrough and having a length sufficient toprovide fluid communication between an anterior chamber and a tear filmof the eye through the second lumen when the device is implanted in asclera of the eye.
 19. The two-piece device of claim 18, wherein thecollar has a length sufficient to extend from an outer surface of theeye to the anterior chamber while the collar is implanted in the scleraof the eye.
 20. The two-piece device of claim 18, wherein the at least aportion of the cartridge is releasably engageable within the first lumenusing a dimensional interference fit therebetween.
 21. The two-piecedevice of claim 18, wherein the collar includes one or more barbsconfigured to engage the sclera while the collar is implanted in thesclera of the eye. 22.-27. (canceled)
 28. The device of claim 1, whereinthe device further comprises one or more lateral barbs extending fromthe external surface of the device.